(31 days)
These devices are intended to be used as replacement door assemblies for Baxter Flo-Gard 6201 and Baxter Flo-Gard® 6301 volumetric infusion pumps, for use to deliver drug solutions, enteral feedings and blood.
AIV's pump door assemblies are replacements for similar doors manufactured by Baxter Healthcare Corporation for their Flo-Gard® 6201 and Flo-Gard® 6301 Volumetric Infusion Pumps. The door is part of a linear peristaltic pumping mechanism. The door assemblies are intended to be direct replacement for the predicate device door assembly.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AIV Replacement Pump Head Door Assembly:
Acceptance Criteria and Device Performance
The core acceptance criterion for the AIV Replacement Pump Head Door Assembly is its performance in terms of flow volume accuracy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow volume within 7% of programmed volume for a programmed flow rate | "Bench Testing demonstrates that the AIV devices perform as intended and are equivalent to predicate device assemblies." |
| (Implicitly, this means they meet the 7% tolerance, as the predicate device has the same performance criteria.) |
Study Information
The provided document describes a bench testing study, but lacks detailed numerical results beyond the general statement of equivalence.
-
Sample size for the test set and data provenance:
- Sample Size: Not explicitly stated. The document refers to "Bench Testing" and "AIV devices," but does not provide the number of units tested.
- Data Provenance: Not explicitly stated, but can be inferred as retrospective as it's a comparison to established predicate devices. The study was conducted by the manufacturer, American IV Products, Inc. (AIV). The country of origin of the data is likely USA, as the submitting company is based in Maryland.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. This was a bench test comparing the functional performance of the AIV device to its predicate. Ground truth in this context would likely be established by validated test equipment and calibration standards, not expert human assessment.
-
Adjudication method for the test set:
- Not applicable for this type of bench testing. Performance would be objectively measured using calibrated instruments against a defined specification.
-
Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study was not conducted. This device is a component of an infusion pump, and its performance is assessed via engineering bench tests, not human interpretation of medical cases.
-
Standalone (algorithm-only) performance:
- Yes, a standalone performance evaluation was done in the sense that the AIV device was tested on its own (or in place of the predicate device component) to verify its functional performance. This is an engineering test, not an algorithm-only test in the context of AI/ML.
-
Type of ground truth used:
- The ground truth for this study is the established performance specifications of the predicate device (Baxter Flo-Gard 6201 and 6301) and general engineering standards for flow rate accuracy. This is based on objective, quantifiable measurements.
-
Sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "design" and "materials" were presumably developed through engineering processes, prototyping, and testing, but not in the sense of a dataset for machine learning.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the design of the AIV device was the existing, legally marketed predicate devices and their known performance characteristics.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).